Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.

Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing

The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is:

• Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments?

Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise.

Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.

Study Overview

• Status: Recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Procedure: Non-surgical treatment of peri-implantitis with air polishing; Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elin Hadler-Olsen, PhD; Phone Number: +47 48 06 72 49; Email: elin.hadlerolsen@tffk.no

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9271
      • Recruiting
      • Tannhelsetjenestens kompetansesenter for Nord-Norge
      • Contact: Elin Hadler-Olsen; Phone Number: +4748067249; Email: elin.hadlerolsen@tffk.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis
• Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting.

Exclusion Criteria:

• Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical debridement	Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement; Non-surgical treatment of peri-implantitis with mechanical debridement .
Experimental: Air polishing	Procedure: Non-surgical treatment of peri-implantitis with air polishing; Non-surgical treatment of peri-implantitis with air polishing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	Probing depth 5 millimeters or more	26 weeks
Bleeding on probing	Bleeding from pocket on pocket depth probing	26 weeks
Suppuration on probing	Suppuration from pocket on pocket depth probing	26 weeks

Collaborators and Investigators

• Sponsor: Tannhelsetjenestens Kompetansesenter for Nord-Norge
• Collaborators: Malmö University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Air-polishing; Peri-implantitis; Non-surgical treatment; Bleeding on probing; Mechanical debridement; periodontal pocket depth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 343997

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No